Senator Schumer Proposes Track -And-Trace System For Prescription Drugs To Prevent Contamination

Tainted Heparin Linked To 81 Deaths; Blood Thinner Originating From China Contained Deadly Contaminant

April 22, 2008 -- WASHINGTON, DC--U.S. Senator Charles E. Schumer (D-NY) announced Tuesday he will introduce legislation this week establishing a modern track-and-trace system for all prescription drugs sold in the United States, a move he said would cut down on the contamination of popular patient medicines like the embattled blood thinner, heparin.

Heparin syringe: Photo by flaviab (CC)

Schumer made the announcement one day after U.S. health officials announced they had linked a contaminant found in Chinese-produced batches of heparin to severe reactions responsible for at least 81 U.S. deaths.

"There shouldn't be any mystery about where our drugs and their ingredients come from," Schumer said. "A national tracking system would give every drug bought and sold in the U.S. a unique identity, and make its entire life history easily traceable. A solution as simple as putting a barcode on the container can greatly improve consumer safety and confidence."

Schumer's "pedigree" legislation improves upon a proposed state law that California had to delay last month amid outcries by prescription drug manufacturers and distributors. The Schumer bill would help verify the integrity of medicines by making every aspect of its life cycle, from manufacture to point of sale, traceable through a unique identifier like a barcode. Schumer said the tracking system would prevent contaminated or adulterated prescription drugs from reaching consumers, as has occurred more frequently of late, and with tragic results.

Consumer concerns about the drug supply system have been addressed by a patchwork of state laws. Most recently, in March, implementation of California's 2004 pedigree law was delayed because of unworkable timelines. The law was set to take effect January 1 of next year, but will instead remain unimposed until 2011. Manufacturers had complained that the California statute would require the implementation of technology that isn't ready yet, and require them to repackage their products to outfit them with barcode labels. The pharmaceutical industry has also argued that a federal registration system makes more sense than a patchwork of conflicting regulatory systems among the states.

Schumer's bill would create a national standard, across all 50 states, for modernized tracking of drugs. It would require drug manufacturers to assign a unique serial number, which allows for more sophisticated tracking, to all product sold in the United States. A simple scan would reveal the life history of the drug's manufacture and wholesaling. Drug companies have already implemented such technology when it has been in their own commercial interest. For instance, Pfizer assigns serial numbers to containers of its popular male enhancement drug, Viagra--a frequent target of counterfeiters. In addition, Schumer's bill would preempt state law, allowing for a much needed, uniform national solution to ensure the integrity of the drug supply chain. Schumer's bill focuses on using tracking and tracking technology that has been proven to be effective and interoperable across the supply chain.

The problem of counterfeit prescription drugs has received renewed attention lately due to a run of health problems caused by a batch of heparin that Food and Drug Administration (FDA) officials have reported contained chondroitin sulfate. Baxter, the manufacturer of heparin, relies on low-cost, Chinese-made ingredients to produce the drug. But both the company and Chinese health officials failed to identify the presence of the Chinese-sourced contaminant that has now affected batches of the drug in 11 countries. The FDA admitted yesterday it could not discern at what point in heparin's supply chain the contamination had occurred, showing the need for Schumer's legislation.

Source: Senator Charles E. Schumer

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